EMA于2000年颁布《Note for Guidance on theInvestigation of Bioavailability and Bioequivalence》( 生物利用度和生物等效性研究指导原则备注) 提及HVD,但未明确具体研究方法。 2010年,《Guidance on the Investigation of Bioequivalence》( 生物等效性研究指导原则) 对既往指导原则做了修订,并明确规定HVD定义、试验设计...
2 This guidance has been developed based on the deliberations of two workshops: (1) Analytical Methods Validation: Bioavailability, Bioequivalence, and Pharmacokinetic Studies (held on December 3B5, 19902 ) and (2) Bioanalytical Methods Validation C A Revisit With a Decade of Progress (held on ...
EMA于2000年颁布《Note for Guidance on theInvestigation of Bioavailability and Bioequivalence》( 生物利用度和生物等效性研究指导原则备注) 提及HVD,但未明确具体研究方法。 2010年,《Guidance on the Investigation of Bioequivalence》( 生物等效性研究指导原则) 对既往指导原则做了修订,并明确规定HVD定义、试验设计...
为对我国正在进行的仿制药质量和疗效一致性评价工作提供借鉴和帮助,指导BE试验的开展,中国药学会组织专家对美国FDA《特定药物的生物等效性指导原则》(Guidance for Industry BioequivalenceRecommendations for Specific Products)的部分内容进行了翻译,中文翻译稿已于2016年5月17日在相关网站(http://www.nifdc.org.cn/fzy...
I. INTRODUCTION 引言 This guidance helps sponsors of investigational new drug applications (INDs) or applicants of new drug applications (NDAs), abbrevi
Individual Bioequivalence—A Review of the FDA Draft Guidance As more generic drugs become available in the marketplace, it is a public concern whether the quality, safety, and efficacy of generic drugs are the same a... Chow,S.-C. - 《Therapeutic Innovation & Regulatory Science》 被引量:...
美国FDA 指导原则 简明新药申请条件下药物的生物等效性研究 英文原版.pdf,Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment pur
Gao J. Bioanalytical method validation for studies on pharmacokinetics, bioavailability and bioequivalence: High- lights of the FDA's Guidance. Asian J Drug... J Gao - 《Asia.j.dru.metab.pharmaco》 被引量: 21发表: 2004年 Recommendations and Best Practices for Reference Standards and Reagents Us...
FDA Issues Guidance on Bioequivalence
of an ANDA, FDA filing decisions, drug master files, product quality, and bioequivalence are ...